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Abstract:

A hermetically sealed feedthrough for attachment to an active implantable
medical device includes a dielectric substrate configured to be
hermetically sealed to a ferrule or an AIMD housing. A via hole is
disposed through the dielectric substrate from a body fluid side to a
device side. A conductive fill is disposed within the via hole forming a
filled via electrically conductive between the body fluid side and the
device side. A conductive insert is at least partially disposed within
the conductive fill. Then, the conductive fill and the conductive insert
are co-fired with the dielectric substrate to form a hermetically sealed
and electrically conductive pathway through the dielectric substrate
between the body fluid side and the device side.

Claims:

1. A hermetically sealed feedthrough for attachment to an active
implantable medical device (AIMD), the feedthrough comprising: a
dielectric substrate configured to be hermetically sealed to a ferrule or
an active implantable medical device housing; a via hole disposed through
the dielectric substrate from a first side to a second side; a conductive
fill disposed within the via hole forming a filled via electrically
conductive between the first side and the second side; and a conductive
insert at least partially disposed within the conductive fill; wherein
the conductive fill and the conductive insert are co-fired with the
dielectric substrate forming a hermetically sealed and electrically
conductive pathway through the dielectric substrate between the first
side and the second side.

3. The feedthrough of claim 2, wherein the conductive insert comprises a
substantially pure metallic insert, where the metallic insert and the
metallic fill are of the same metallic material.

4. The feedthrough of claim 3, wherein an inherent shrink rate during a
co-firing treatment of the dielectric substrate in a green state is
greater than that of an inherent shrink rate during the co-firing
treatment of the metallic fill in a green state.

8. The feedthrough of claim 7, wherein the hermetically sealed and
electrically conductive pathway comprises a first hermetic seal between
the platinum fill and the alumina ceramic substrate, wherein the platinum
fill forms a tortuous and mutually conformal knitline or interface
between the alumina ceramic substrate and the platinum fill.

9. The feedthrough of claim 8, wherein the hermetically sealed and
electrically conductive pathway comprises a second hermetic seal between
the platinum fill and the platinum insert, wherein the platinum fill
forms a second tortuous and mutually conformal knitline or interface
between the platinum fill and the platinum insert.

10. The feedthrough of claim 9, wherein at least a portion of an outer
surface of the platinum insert forming the second tortuous and mutually
conformal knitline or interface comprises a substantially irregular
surface.

11. The feedthrough of claim 1, wherein the conductive insert is exposed
through the conductive fill on the first side or the second side of the
dielectric substrate.

12. The feedthrough of claim 11, wherein the conductive insert is flush
with a first side surface or a second side surface of the dielectric
substrate.

13. The feedthrough of claim 11, wherein the conductive insert extends
beyond a first side surface or a second side surface of the dielectric
substrate.

14. The feedthrough of claim 13, wherein the conductive insert comprises
an enlarged end cap on the first side or the second side of the
dielectric substrate.

15. The feedthrough of claim 11, wherein the conductive insert comprises
a first portion separate and distinct from a second portion, where the
first and second portions are configured to be adjacent to or abut one
another when disposed from opposite sides of the first side and the
second side through the conductive fill.

16. The feedthrough of claim 1, wherein the conductive insert comprises a
crimp post extending beyond the first side or the second side of the
dielectric substrate.

17. The feedthrough of claim 16, wherein the crimp post comprises a
receptacle configured to receive a conductive wire, wherein the crimp
post comprises a cross-sectional shape of a circle, an oval, a rectangle
or a square.

18. The feedthrough of claim 17, wherein the receptacle of the crimp post
is disposed perpendicular to a longitudinal length of the crimp post.

19. The feedthrough of claim 17, wherein the receptacle of the crimp post
is aligned with a longitudinal length of the crimp post.

20. The feedthrough of claim 17, wherein the crimp post comprises at
least one slot at least partially disposed along a longitudinal length of
the crimp post.

21. The feedthrough of claim 20, wherein the at least one slot is fully
disposed along the longitudinal length of the crimp post.

22. The feedthrough of claim 1, including a feedthrough capacitor
disposed on the second side of the dielectric substrate, the feedthrough
capacitor comprising at least one active electrode plate separated from
at least one ground electrode plate by a capacitor dielectric, wherein
the at least one active electrode plate is electrically coupled to the
conductive pathway and wherein the at least one ground electric plate is
electrically coupled to the ferrule or AIMD housing, wherein the
feedthrough capacitor forms a frequency selective diverter circuit
between the conductive pathway and to the ferrule or AIMD housing.

23. The feedthrough of claim 1, including a circuit board disposed on the
second side of the dielectric substrate, wherein the circuit board
comprises at least one monolithic chip capacitor (MLCC) electrically
coupled between the conductive pathway and to the ferrule or AIMD
housing, where the MLCC forms a frequency selective diverter circuit
between the conductive pathway and to the ferrule or AIMD housing.

24. The feedthrough of claim 1, including a shielded three-terminal
flat-through EMI energy dissipating filter disposed on the second side of
the dielectric substrate, the flat-through filter comprising: i) at least
one active electrode plate through which a circuit current is configured
to pass between a first terminal and a second terminal; ii) at least one
first shield plate disposed on a first side of the at least one active
electrode plate; and iii) at least one second shield plate disposed on a
second side of the at least one active electrode plate, where the at
least one second shield plate is disposed opposite the at least one first
shield plate; iv) wherein the at least one first and second shield plates
are both electrically coupled to a third terminal, where the third
terminal is configured to be electrically coupled directly or indirectly
to the ferrule or the AIMD housing; v) wherein the conductive pathway is
electrically coupled directly or indirectly to the at least one active
electrode plate and where the conductive pathway is in non-conductive
relationship to the at least one first and second shield plates, the
ferrule and the AIMD housing.

26. The feedthrough of claim 1, wherein the conductive fill has a larger
cross-sectional area at the first side or second side as compared to a
center portion of the conductive fill.

27. The feedthrough of claim 1, wherein the first side of the dielectric
substrate is one of a body fluid side or a device side, and the second
side of the dielectric substrate is the other of the body fluid side or
the device side.

28. The feedthrough of claim 1, wherein the first side of the dielectric
substrate is of a body fluid side, and the second side of the dielectric
substrate is of a device side.

29. A hermetically sealed feedthrough for attachment to an active
implantable medical device (AIMD), the feedthrough comprising: an alumina
substrate comprised of at least 96 percent alumina and having a thickness
extending from a first side to a second side, where the alumina substrate
is hermetically sealed to a ferrule or an active implantable medical
device housing; a via hole disposed through the alumina substrate from
the first side to the second side; a substantially closed pore and
substantially pure platinum fill disposed within the via hole forming a
filled via electrically conductive between the first side and the second
side; and a substantially pure platinum insert at least partially
disposed within the platinum fill; wherein the platinum fill and the
platinum insert are co-fired with the alumina substrate to form a
hermetically sealed and electrically conductive pathway through the
alumina substrate between the first side and the second side; and wherein
the hermetically sealed and electrically conductive pathway comprises a
first hermetic seal between the platinum fill and the alumina substrate,
wherein the platinum fill forms a tortuous and mutually conformal
knitline or interface between the alumina substrate and the platinum
fill.

30. The feedthrough of claim 29, wherein the hermetically sealed and
electrically conductive pathway comprises a second hermetic seal between
the platinum fill and the platinum insert, wherein the platinum fill
forms a second tortuous and mutually conformal knitline or interface
between the platinum fill and the platinum insert.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation-in-part application of application Ser. No.
14/182,569 filed on Feb. 18, 2014, which itself was a division of
application Ser. No. 13/743,254 filed on Jan. 16, 2013 and now U.S. Pat.
No. 8,653,384 issued on Feb. 18, 2014, which itself claimed priority to
three provisional applications which are U.S. Application Ser. Nos.
61/587,029, filed on Jan. 16, 2012; 61/587,287, filed on Jan. 17, 2012;
and 61/587,373, filed on Jan. 17, 2012. The contents of all the above
mentioned applications are herein incorporated in full with these
references.

DESCRIPTION

[0002] 1. Field of the Invention

[0003] The present invention generally relates to implantable medical
devices and hermetic terminal subassemblies. More particularly, the
present invention relates to a hermetic terminal subassembly utilizing a
co-fired essentially pure platinum filled via along with novel ways of
making electrical connections on the body fluid and device side of the
active implantable medical device (AIMD) housing.

[0004] 2. Background of the Invention

[0005] A wide assortment of active implantable medical devices (AIMD) are
presently known and in commercial use. Such devices include cardiac
pacemakers, cardiac defibrillators, cardioverters, neurostimulators, and
other devices for delivering and/or receiving electrical signals to/from
a portion of the body. Sensing and/or stimulating leads extend from the
associated implantable medical device to a distal tip electrode or
electrodes in contact with body tissue.

[0006] The hermetic terminal or feedthrough of these implantable devices
is considered critical. Hermetic terminals or feedthroughs are generally
well-known in the art for connecting electrical signals through the
housing or case of an AIMD. For example, in implantable medical devices
such as cardiac pacemakers, implantable cardioverter defibrillators, and
the like, a hermetic terminal comprises one or more conductive terminal
pins supported by an insulative structure for feedthrough passage from
the exterior to the interior of an AIMD electromagnetic shield housing.
Hermetic terminals or feedthroughs for AIMDs must be biocompatible as
well as resistant to degradation under applied bias current or voltage.
Hermeticity of the feedthrough is imparted by judicious material
selection and carefully prescribed manufacturing processing. Sustainable
hermeticity of the feedthrough over the lifetime of these implantable
devices is critical because the hermetic terminal intentionally isolates
the internal circuitry and components of the device from the external
environment to which the component is exposed. In particular, the
hermetic terminal isolates the internal circuitry, connections, power
sources and other components in the device from ingress of body fluids.
Ingress of body fluids into an implantable medical device is known to be
a contributing factor to device malfunction and may contribute to the
compromise or failure of electrical circuitry, connections, power sources
and other components within an implantable medical device that are
necessary for consistent and reliable device therapy delivery to a
patient. Furthermore, ingress of body fluids may compromise an
implantable medical device's functionality which may constitute
electrical shorting, element or joint corrosion, metal migration or other
such harmful consequences affecting consistent and reliable device
therapy delivery.

[0007] In addition to concerns relative to sustained terminal or
feedthrough hermeticity, other potentially compromising conditions must
be addressed, particularly when a hermetic terminal or feedthrough is
incorporated within an implantable medical device. For example, the
hermetic terminal or feedthrough pins are typically connected one or more
leadwires of implantable therapy delivery leads. These implantable
therapy delivery leads can effectively act as antennas of electromagnetic
interference (EMI) signals. Therefore, when these electromagnetic signals
enter within the interior space of a hermetic implantable medical device,
facilitated by the therapy delivery leads, they can negatively impact the
intended function of the medical device and as a result, negatively
impact therapy delivery intended for a patient by that device. EMI
engineers commonly refer to this as the "genie in the bottle" effect. In
other words, once the genie (i.e., EMI) is inside the hermetic device, it
can wreak havoc with electronic circuit functions by cross-coupling and
re-radiating within the device.

[0008] Another particularly problematic condition associated with
implanted therapy delivery leads occurs when a patient is in an MRI
environment. In this case, the electrical currents imposed on the
implanted therapy delivery leads can cause the leads to heat to the point
where tissue damage is likely. Moreover, the electrical currents
developed in these implanted therapy delivery leads during an MRI
procedure can disrupt or damage the sensitive electronics within the
implantable medical device.

[0009] Therefore, materials selection and fabrication processing
parameters are of utmost importance in creating a hermetic terminal (or
feedthrough) or a structure embodying a hermetic terminal (or
feedthrough), that can survive anticipated and possibly catastrophically
damaging environmental conditions and that can be practically and cost
effectively manufactured.

[0010] Hermetic terminals or feedthrough assemblies utilizing ceramic
dielectric materials may fail in a brittle manner. A brittle failure
typically occurs when the ceramic structure is deformed elastically up to
an intolerable stress, at which point the ceramic fails catastrophically.
Virtually all brittle failures occur by crack propagation in a tensile
stress field. Even microcracking caused by sufficiently high tensile
stress concentrations may result in a catastrophic failure including loss
of hermeticity identified as critical in hermetic terminals for
implantable medical devices. Loss of hermeticity may be a result of
design aspects such as a sharp corner which creates a stress riser,
mating materials with a difference of coefficient of thermal expansions
(CTE) that generate tensile stresses that ultimately result in loss of
hermeticity of the feedthrough or interconnect structure.

[0011] In the specific case of hermetic terminal or feedthrough designs, a
tensile stress limit for a given ceramic based hermetic design structure
cannot be specified because failure stress in these structures is not a
constant. As indicated above, variables affecting stress levels include
the design itself, the materials selection, symmetry of the feedthrough,
and the bonding characteristics of mating surfaces within the
feedthrough. Hence, length, width and height of the overall ceramic
structure matters as do the number, spacing, length and diameter of the
vias in that structure. The selection of the mating materials, that is,
the material that fills the vias and the material that forms the base
ceramic, are important. Finally, the fabrication processing parameters,
particularly at binder burnout, sintering and cool down, make a
difference. When high reliability is required in an application such as
indicated with hermetic terminals or feedthroughs for AIMDs, to provide
ensurance for a very low probability of failure it is necessary to design
a hermetic terminal assembly or feedthrough structure so that stresses
imparted by design, materials and/or processing are limited to a smaller
level of an average possible failure stress. Further, to provide
ensurance for a very low probability of failure in a critical ceramic
based assembly or subassembly having sustainable hermetic requirements,
it is also necessary to design structures embodying a hermetic terminal
or feedthrough such that stresses in the final assembly or subassembly
are limited to a smaller level of an average possible failure stress for
the entire assembly or subassembly. In hermetic terminals and structures
comprising hermetic terminals for AIMDs wherein the demand for
biocompatibility exists, this task becomes even more difficult.

[0012] The most critical feature of a feedthrough design or any terminal
subassembly is the metal/ceramic interface within the feedthrough that
establishes the hermetic seal. The present invention therefore, provides
a hermetic feedthrough comprising a monolithic alumina insulator
substrate within which a platinum conductive pathway or via resides. More
specifically, the present invention provides a hermetic feedthrough in
which the hermetic seal is created through the intimate bonding of the
platinum metal residing within the alumina substrate.

[0013] A traditional ceramic-to-metal hermetic terminal is an assembly of
three components: metal leadwires that conduct electrical current, a
ceramic insulator, and a metal housing, which is referred to as the
flange or the ferrule. Brazed joints hermetically seal the metal
leadwires and the flange or ferrule to the ceramic insulator. For a
braze-bonded joint, the braze material is generally intended to deform in
a ductile manner in order to compensate for perturbations that stress the
bond between the mating materials as the braze material may provide
ductile strain relief when the thermal expansion mismatch between the
ceramic and metal is large. Thus, mating materials with large mismatches
in CTE can be coupled through braze materials whose high creep rate and
low yield strength reduce the stresses generated by the differential
contraction existing between these mating materials.

[0014] Thermal expansion of metal is generally considerably greater than
those of ceramics. Hence, successfully creating a hermetic structure, and
one that can sustain its hermeticity in service, is challenging due to
the level of residual stresses in the final structure. Specifically,
thermal expansion mismatch results in stresses acting along the
ceramic/metal interface that tend to separate the ceramic from the metal
and so the bond developed between the ceramic and the metal must be of
sufficient strength to withstand these stresses, otherwise adherence
failure, that is, loss of hermeticity, will occur. One method for
limiting these stresses is to select combinations of materials whose
thermal contractions after bonding are matched.

[0015] In making the selection for a CTE match, it is important to note
that very few pairs of materials have essentially identical thermal
expansion curves. Generally, the metal component is selected first based
on electrical and thermal conductivity, thermal expansion, ability to be
welded or soldered, mechanical strength, and chemical resistance or
biocompatibility requirements; the ceramic is then selected based
primarily on electrical resistivity, dielectric strength, low gas
permeability, environmental stability, and thermal expansion
characteristics. In the specific case of selecting platinum wire, often
the ceramic formulation is modified in order to match its CTE to that of
the platinum wire. In yet a more specific case of selecting platinum
paste, the platinum paste formulation may be modified as well. If the
mating materials are alumina of at least 96% purity and essentially pure
platinum paste, then matching CTE is not possible. Thus, for AIMD's,
consistently achieving hermetic terminal structures that are capable of
sustaining hermeticity throughout the application's service life has
proven challenging.

[0016] Producing a stress-free structure often not only involves bonding a
pair of materials but also achieving that bond at a very specific
temperature so that their contractions on cooling to room temperature are
essentially the same even though the contraction curves may not coincide.
Since this often is a significant challenge, hermetic terminals are
produced by metalizing the alumina and using a brazing material to form
the bond at some other temperature than an intersection of the CTE
curves. (NOTE: Forming a bond between two materials that become rigid at
the intersection of the two CTE curves makes it possible to produce a
structure that is stress free at room temperature, unless the two CTE
curves separate substantially from each other from the intersection point
and room temperature.) The deformation of the braze material by
time-independent plastic flow or creep relaxation limits the stresses
generated in the ceramic. Given this, the impact of the rate of cooling
on the final stress level of a structure must also be considered. In some
cases, residual stresses are generated deliberately to provide protective
compressive stresses in the ceramic part and in the bond interface.
Usually this is accomplished by selecting components with different CTEs.
Another way is to control the shrinkage of one material over its mating
material. In either case, it is important to minimize stress levels such
that the interface on which hermeticity depends is well within the stress
level at which failure might occur.

[0017] In an embodiment, the present invention is directed to mating bound
particulate high purity alumina of at least 96% and particles of
essentially pure platinum metal that are suspended within a mixture of
solvents and binders, i.e. a platinum paste. This combination of
materials does not use a braze material to buffer the CTE mismatch
between these two materials. Further, since the intent of this invention
is to provide hermetic terminals and subassemblies comprising hermetic
terminals for AIMDs, the present invention does not consider
modifications to the alumina formulation or the platinum paste in an
attempt to match their CTEs. Rather, this invention discloses sustainable
hermetic terminals and structures embodying these hermetic terminals.
This is achieved by adjusting platinum paste solids loading, prescribing
via packing, prescribing binder burnout, sintering and cool down
parameters, such that shrinkage of the alumina is greater than the
shrinkage of the platinum fill in the via and an intimate and tortuous (a
mutually conformal) interface is created that may be a direct bond
between the alumina and platinum materials that is hermetic.
Alternatively, or that may develop an amorphous interfacial layer that is
not susceptible to erosion by body fluids and can tolerate stress levels
without losing hermeticity.

[0018] Regarding EMI, a terminal or feedthrough capacitor EMI filter may
be disposed at, near or within a hermetic terminal or feedthrough
resulting in a feedthrough filter capacitor which diverts high frequency
electrical signals from lead conductors to the housing or case of an
AIMD. Many different insulator structures and related mounting methods
are known in the art for use of feedthrough capacitor EMI filters in
AIMDs, wherein the insulative structure also provides a hermetic terminal
or feedthrough to prevent entry of body fluids into the housing of an
AIMD. In the prior art devices, the hermetic terminal subassembly has
been combined in various ways with a ceramic feedthrough filter EMI
capacitor to decouple interference signals to the housing of the medical
device.

[0019] In a typical prior art unipolar construction (as described in U.S.
Pat. No. 5,333,095 and herein incorporated by reference), a
round/discoidal (or rectangular) ceramic feedthrough EMI filter capacitor
is combined with a hermetic terminal pin assembly to suppress and
decouple undesired interference or noise transmission along a terminal
pin. The feedthrough capacitor is coaxial having two sets of electrode
plates embedded in spaced relation within an insulative dielectric
substrate or base, formed typically as a ceramic monolithic structure.
One set of the electrode plates are electrically connected at an inner
diameter cylindrical surface of the coaxial capacitor structure to the
conductive terminal pin utilized to pass the desired electrical signal or
signals. The other or second set of electrode plates are coupled at an
outer diameter surface of the round/discoidal capacitor to a cylindrical
ferrule of conductive material, wherein the ferrule is electrically
connected in turn to the conductive housing of the electronic device. The
number and dielectric thickness spacing of the electrode plate sets
varies in accordance with the capacitance value and the voltage rating of
the coaxial capacitor. The outer feedthrough capacitor electrode plate
sets (or "ground" plates) are coupled in parallel together by a metalized
layer which is either fired, sputtered or plated onto the ceramic
capacitor. This metalized band, in turn, is coupled to the ferrule by
conductive adhesive, soldering, brazing, welding, or the like. The inner
feedthrough capacitor electrode plate sets (or "active" plates) are
coupled in parallel together by a metalized layer which is either glass
frit fired or plated onto the ceramic capacitor. This metalized band, in
turn, is mechanically and electrically coupled to the lead wire(s) by
conductive adhesive, soldering, or the like. In operation, the coaxial
capacitor permits passage of relatively low frequency biologic signals
along the terminal pin, while shielding and decoupling/attenuating
undesired interference signals of typically high frequency to the AIMD
conductive housing. Feedthrough capacitors of this general type are
available in unipolar (one), bipolar (two), tripolar (three), quadpolar
(four), pentapolar (five), hexpolar (6) and additional lead
configurations. The feedthrough capacitors (in both discoidal and
rectangular configurations) of this general type are commonly employed in
implantable cardiac pacemakers and defibrillators and the like, wherein
the pacemaker housing is constructed from a biocompatible metal such as
titanium alloy, which is electrically and mechanically coupled to the
ferrule of the hermetic terminal pin assembly which is in turn
electrically coupled to the coaxial feedthrough filter capacitor. As a
result, the filter capacitor and terminal pin assembly prevents entrance
of interference signals to the interior of the pacemaker housing, wherein
such interference signals could otherwise adversely affect the desired
cardiac pacing or defibrillation function.

[0020] Regarding MRI related issues, bandstop filters, such as those
described in U.S. Pat. No. 6,008,980, which is herein incorporated by
reference, reduce or eliminate the transmission of damaging frequencies
along the leads while allowing the desired biologic frequencies to pass
efficiently through.

[0021] Referring once again to feedthrough capacitor EMI filter
assemblies, although these assemblies as described earlier have performed
in a generally satisfactory manner, and notwithstanding that the
associated manufacturing and assembly costs are unacceptably high in that
the choice of the dielectric material for the capacitor has significant
impacts on cost and final performance of the feedthrough filter
capacitor, alumina ceramic has not been used in the past as the
dielectric material for AIMD feedthrough capacitors. Alumina ceramic is
structurally strong and biocompatible with body fluids but has a
dielectric constant around 6 (less than 10). There are other more
effective dielectric materials available for use in feedthrough filter
capacitor designs. Relatively high dielectric constant materials (for
example, barium titanate with a dielectric constant of over 2,000) are
traditionally used to manufacture AIMD feedthrough capacitors for
integrated ceramic capacitors and hermetic seals resulting in more
effective capacitor designs. Yet ceramic dielectric materials such as
barium titanate are not as strong as the alumina ceramic typically used
to manufacture the hermetic seal subassembly in the prior art. Barium
titanate is also not biocompatible with body fluids. Direct assembly of
the ceramic capacitor can result in intolerable stress levels to the
capacitor due to the mismatch in thermal coefficients of expansion
between the titanium pacemaker housing (or other metallic structures) and
the capacitor dielectric. Hence, particular care must be used to avoid
cracking of the capacitor element. Accordingly, the use of dielectric
materials with a low dielectric constant and a relatively high modulus of
toughness are desirable yet still difficult to achieve for
capacitance-efficient designs.

[0022] Therefore, it is very common in the prior art to construct a
hermetic terminal subassembly with a feedthrough capacitor attached near
the inside of the AIMD housing on the device side. The feedthrough
capacitor does not have to be made from biocompatible materials because
it is located on the device side inside the AIMD housing. The hermetic
terminal subassembly allows leadwires to hermetically pass through the
insulator in non-conductive relation with the ferrule or the AIMD
housing. The leadwires also pass through the feedthrough capacitor to the
inside of the AIMD housing. These leadwires are typically continuous and
must be biocompatible and non-toxic. Generally, these leadwires are
constructed of platinum or platinum-iridium, palladium or
palladium-iridium, niobium or the like. Platinum-iridium is an ideal
choice because it is biocompatible, non-toxic and is also mechanically
very strong. The iridium is added to enhance material stiffness and to
enable the hermetic terminal subassembly leadwire to sustain bending
stresses. An issue with the use of platinum for leadwires is that
platinum has become extremely expensive and may be subject to premature
fracture under rigorous processing such as ultrasonic cleaning or
application use/misuse, possibly unintentional damaging forces resulting
from Twiddler's Syndrome.

[0023] Accordingly, what is needed is a filtered structure like a hermetic
terminal or feedthrough, any subassembly made using same and any
feedthrough filter EMI capacitor assembly which minimizes intolerable
stress levels, allows use of preferred materials for AIMDS and eliminates
high-priced, platinum, platinum-iridium or equivalent noble metal
hermetic terminal subassembly leadwires. Also, what is needed is an
efficient, simple and robust way to connect the leadwires in a header
block to the novel hermetic terminal subassembly. Correspondingly, it is
also needed to make a similar efficient, simple and robust electrical
connection between the electronics on the device side of the AIMD to the
feedthrough capacitor and hermetic terminal subassembly. The present
invention fulfills these needs and provides other related advantages.

SUMMARY OF THE INVENTION

[0024] An exemplary embodiment of a hermetically sealed feedthrough for
attachment to an active implantable medical device includes a dielectric
substrate configured to be hermetically sealed to a ferrule or an AIMD
housing. A via hole is disposed through the dielectric substrate from a
body fluid side to a device side. A conductive fill is disposed within
the via hole forming a filled via electrically conductive between the
body fluid side and the device side. A conductive insert is at least
partially disposed within the conductive fill. The conductive fill and
the conductive insert are co-fired with the dielectric substrate to form
a hermetically sealed and electrically conductive pathway through the
dielectric substrate between the body fluid side and the device side.

[0025] In other exemplary embodiments the conductive fill may include a
substantially closed pore and substantially pure metallic fill. The
conductive insert may include a substantially pure metallic insert, where
the metallic insert and the metallic fill are of the same metallic
material type. An inherent shrink rate during a co-firing treatment of
the dielectric substrate in a green state may be greater than that of an
inherent shrink rate during the co-firing treatment of the metallic fill
in a green state.

[0026] In other exemplary embodiments the conductive fill may include a
substantially closed pore and substantially pure platinum fill. The
conductive insert may include a substantially pure platinum insert. The
dielectric substrate may include an alumina substrate comprised of at
least 96 percent alumina. The hermetically sealed and electrically
conductive pathway may include a first hermetic seal between the platinum
fill and the alumina dielectric substrate, wherein the platinum fill
forms a tortuous and mutually conformal knitline or interface between the
alumina substrate and the platinum fill. The hermetically sealed and
electrically conductive pathway may include a second hermetic seal
between the platinum fill and the platinum insert, wherein the platinum
fill forms a second tortuous and mutually conformal knitline or interface
between the platinum fill and the platinum insert. At least a portion of
an outer surface of the platinum insert may be forming the second
tortuous and mutually conformal knitline or interface comprises a
substantially irregular surface.

[0027] The conductive insert may be exposed through the conductive fill on
the body fluid side or the device side of the dielectric substrate. The
conductive insert may be flush with a device side surface or a body fluid
side surface of the dielectric substrate. The conductive insert may
extend beyond a device side surface or a body fluid side surface of the
dielectric substrate. The conductive insert may include an enlarged end
cap on the device side or the body fluid side of the dielectric
substrate. The conductive insert may include a first portion separate and
distinct from a second portion, where the first and second portions are
configured to abut one another when disposed from opposite sides of the
body fluid side and the device side through the conductive fill.

[0028] The conductive insert may include a crimp post extending beyond a
device side surface or a body fluid side surface of the dielectric
substrate. The crimp post may include a receptacle configured to receive
a conductive wire, wherein the crimp post comprises a cross-sectional
shape of a circle, an oval, a rectangle or a square. The crimp post may
include at least one slot at least partially disposed along a
longitudinal length of the crimp post. The at least one slot may be fully
disposed along the longitudinal length of the crimp post.

[0029] A feedthrough capacitor may be disposed on the device side of the
dielectric substrate, the feedthrough capacitor comprising at least one
active electrode plate separated from at least one ground electrode plate
by a capacitor dielectric, wherein the at least one active electrode
plate is electrically coupled to the conductive pathway and wherein the
at least one ground electric plate is electrically coupled to the ferrule
or AIMD housing, wherein the feedthrough capacitor forms a frequency
selective diverter circuit between the conductive pathway and to the
ferrule or AIMD housing.

[0030] A circuit board may be disposed on the device side of the
dielectric substrate, wherein the circuit board comprises at least one
monolithic chip capacitor (MLCC) electrically coupled between the
conductive pathway and to the ferrule or AIMD housing, where the MLCC
forms a frequency selective diverter circuit between the conductive
pathway and to the ferrule or AIMD housing.

[0031] A shielded three-terminal flat-through EMI energy dissipating
filter may be disposed on the device side of the dielectric substrate,
the flat-through filter comprising: i) at least one active electrode
plate through which a circuit current is configured to pass between a
first terminal and a second terminal; ii) at least one first shield plate
disposed on a first side of the at least one active electrode plate; and
iii) at least one second shield plate disposed on a second side of the at
least one active electrode plate, where the at least one second shield
plate is disposed opposite the at least one first shield plate; iv)
wherein the at least one first and second shield plates are both
electrically coupled to a third terminal, where the third terminal is
configured to be electrically coupled directly or indirectly to the
ferrule or the AIMD housing; v) wherein the conductive pathway is
electrically coupled directly or indirectly to the at least one active
electrode plate and where the conductive pathway is in non-conductive
relationship to the at least one first and second shield plates, the
ferrule and the AIMD housing.

[0033] The receptacle of the crimp post may be disposed perpendicular to a
longitudinal length of the crimp post. Alternatively, the receptacle of
the crimp post may be aligned with a longitudinal length of the crimp
post.

[0034] The conductive fill may have a larger cross-sectional area at the
device side or body fluid side as compared to a center portion of the
conductive fill.

[0035] Other features and advantages of the present invention will become
apparent from the following more detailed description, when taken in
conjunction with the accompanying drawings, which illustrate, by way of
example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings illustrate the invention. In such
drawings:

[0037] FIG. 1 is a wire-formed diagram of a generic human body showing a
number of exemplary implantable medical devices;

[0038] FIG. 2 is a sectional view of a hermetic insulator with a solid
metallic filled via in a green state;

[0039] FIG. 3 is a sectional view of the structure of FIG. 2 now after
sintering;

[0040] FIG. 4 is an enlarged view taken from FIG. 3 along lines 4-4 now
showing gaps between the solid metallic leadwire and the insulator;

[0041] FIG. 5 is a flow chart illustrating the main steps of one
embodiment of the process of the present invention;

[0042] FIG. 6 is a sectional view of a feedthrough assembly now showing a
wire bond cap co-fired into the platinum filled via;

[0043] FIG. 7 is a sectional view of another feedthrough assembly with a
capacitor mounted on the device side;

[0044] FIG. 8 is a sectional view taken from FIG. 7 along lines 8-8 now
showing the active plates;

[0045] FIG. 9 is a sectional view taken from FIG. 7 along lines 9-9 now
showing the ground plates;

[0046] FIG. 10 is a perspective view of an exemplary embodiment of a round
quad polar hermetic terminal assembly;

[0047] FIG. 11 is a perspective view of an exemplary wire bond pad;

[0048] FIG. 12 is a perspective view of another exemplary wire bond pad;

[0049] FIG. 13 is a perspective view of another exemplary wire bond pad;

[0050] FIG. 14 is a perspective view of another exemplary wire bond pad;

[0051] FIG. 15 is a perspective view of another exemplary embodiment of a
rectangular hermetic terminal subassembly showing castellations;

[0052] FIG. 16 is a perspective view of an embodiment of a wire bond pad;

[0053] FIG. 17 is another perspective view of the embodiment of wire bond
pad in FIG. 16;

[0054] FIG. 18 is a sectional view of the structure of FIG. 17 taken along
lines 18-18;

[0055] FIG. 19 is an enlarged sectional view of the wire bond pad of FIGS.
16-18 co-fired into the platinum filled via;

[0056] FIG. 20 is a perspective view of another embodiment of a wire bond
pad with attachment fingers;

[0057] FIG. 21 is another perspective view of the embodiment of wire bond
pad in FIG. 20;

[0058] FIG. 22 is an enlarged sectional view of another embodiment of a
wire bond pad with a pin co-fired into the platinum filled via;

[0059] FIG. 23 is an enlarged sectional view of another embodiment of a
wire bond pad similar to FIG. 55 now showing a hole to capture the
leadwire;

[0060] FIG. 24 is a sectional view of another exemplary embodiment of a
hermetic terminal subassembly now showing a solid wire co-fired into the
platinum filled via;

[0061] FIG. 25 is a sectional view similar to FIG. 24 now showing a
staggered via hole with a solid wire co-fired into the platinum filled
via;

[0062] FIG. 26 is a sectional view of an exemplary embodiment of a crimp
post co-fired into the platinum filled via;

[0063] FIG. 27 is a sectional view of an exemplary embodiment of a double
crimp post co-fired into the platinum filled via;

[0064] FIG. 28 is a perspective view of an exemplary embodiment of a novel
method of header block connector assembly attachment showing a support
structure behind the wire bond pads;

[0065] FIG. 29 is a perspective view of a wire bond pad similar to FIG. 28
now with a novel slot;

[0066] FIG. 30 is a sectional view with a novel crimp post co-fired into
the platinum filled via;

[0067] FIG. 31 is a perspective view of another exemplary embodiment of a
novel crimp post similar to FIG. 30;

[0068] FIG. 32 is a perspective view of another exemplary embodiment of a
novel crimp post similar to FIG. 30;

[0069] FIG. 33 is a perspective view of another exemplary embodiment of a
novel crimp post similar to FIG. 30;

[0070] FIG. 34 is a perspective view of another exemplary embodiment of a
novel crimp post similar to FIG. 30;

[0071] FIG. 35 is a perspective view of another exemplary embodiment of a
novel crimp post similar to FIG. 30;

[0072] FIG. 36 is a perspective view of a hermetic seal sub-assembly shown
laser welded into an opening in the housing of an active implantable
medical device;

[0073] FIG. 37 shows the device side of a hermetic terminal sub-assembly
now shown on top;

[0074] FIG. 38 is a sectional view taken generally from section 38-38 of
FIG. 36;

[0075] FIG. 39 is a sectional view taken generally from section 39-39 from
FIG. 36;

[0076] FIG. 40 is very similar to FIG. 38 except that in this case, the
conductive inserts can be extended a considerable distance above or below
the entire hermetic seal sub-assembly;

[0077] FIG. 41 is an enlarged view taken from the section at lines 41-41
from FIG. 40;

[0078] FIG. 42 is an enlarged view taken from the section at lines 42-42
from FIG. 41;

[0079] FIG. 43 is an enlarged view taken from the section at lines 43-43
from FIG. 41;

[0080] FIG. 44 is very similar to FIG. 41 except that the conductive
insert is surrounded by a plating, a coating or a cladding material;

[0081] FIG. 45 is very similar to FIGS. 36-38 and is taken generally from
section 45-45 from FIG. 36, except that now the conductive inserts have a
nail head feature;

[0082] FIG. 46 is very similar to FIGS. 45 and 36-38 and is taken
generally from section 46-46 from FIG. 36, except now shows a nail head
feature on the top and bottom;

[0083] FIG. 47 is similar to FIG. 36 except that now the conductive
inserts are in the form of hollow tubelets;

[0084] FIG. 48 shows the hermetic terminal assembly of FIG. 47 now with a
crimp post inverted so one can see the device side on top;

[0085] FIG. 49 is a sectional view taken generally from section 49-49 from
FIG. 47;

[0086] FIG. 50 is a sectional view taken generally from section 50-50 from
FIG. 47;

[0087] FIG. 51 is very similar to FIG. 49 except in this case, there are
crimp posts positioned on both the body fluid side and the device side;

[0088] FIG. 52 is very similar to FIG. 50, now with a crimp post on both
the body fluid side and the device side;

[0089] FIG. 53 is very similar to FIG. 52 except in this case, there is a
slit along the edge of the crimp post;

[0091] FIG. 55 is taken from section 55-55 from FIG. 53 showing the
slotted crimp post in side view;

[0092] FIG. 56 is taken from section 56-56 from FIG. 53 again showing the
slotted crimp post;

[0093] FIG. 57 is very similar to FIG. 53 except that the crimp post has
double slots;

[0094] FIG. 58 is the inverted view of the structure from FIG. 57;

[0095] FIG. 59 is taken from section 59-59 from FIG. 57 showing the double
slotted crimp post in half section;

[0096] FIG. 60 is taken from section 60-60 from FIG. 57 right through the
center of the device, this time going through the center of both slots;

[0097] FIG. 61 is a perspective view showing one embodiment of a crimp
post;

[0098] FIG. 61A is a sectional view of the structure of FIG. 61 taken
along lines 61A-61A;

[0099] FIG. 62 shows another embodiment of a crimp post with two slots;

[0100] FIG. 62A is a sectional view of the structure of FIG. 62 taken
along lines 62A-62A;

[0101] FIG. 63 shows another embodiment of a crimp post with three slots;

[0102] FIG. 63A is a sectional view of the structure of FIG. 63 taken
along lines 63A-63A;

[0103] FIG. 64 shows another embodiment of an oval crimp post;

[0104] FIG. 64A is a sectional view of the structure of FIG. 64 taken
along lines 64A-64A;

[0105] FIG. 65 shows another embodiment of a rectangular or square crimp
post;

[0106] FIG. 65A is a sectional view of the structure of FIG. 65 taken
along lines 65A-65A;

[0107] FIG. 66 shows an embodiment of a hermetical terminal assembly which
has a single slot in the crimp post;

[0108] FIG. 67 shows the perspective view of FIG. 66 inverted so one can
see the device side;

[0109] FIG. 68 is taken from section 68-68 from FIG. 66 illustrating that
the slotted crimp post extending all the way through the conductive
filled via from the body fluid side to the device side;

[0110] FIG. 69 is taken from section 69-69 from FIG. 67 again,
illustrating how the conductive fill penetrates both the outside and the
inside diameter of the crimp post;

[0111] FIG. 70A shows a sectional view through one embodiment of a crimp
post with one slot;

[0112] FIG. 70B shows a sectional view through another embodiment of a
crimp post with two halves;

[0113] FIG. 70C shows a sectional view through another embodiment of a
crimp post with three sections;

[0114] FIG. 70D shows a sectional view through another embodiment of a
crimp post with four sections;

[0115] FIG. 70E shows a sectional view through another embodiment of an
oval crimp post with one slot;

[0116] FIG. 70F shows a sectional view through another embodiment of a
square crimp post having four parts;

[0117] FIG. 71 illustrates that any of the novel hermetic seals of the
present invention can have a device side mounted feedthrough capacitor;
and

[0118] FIG. 72 illustrates an alternative filter embodiment in comparison
to FIG. 71, wherein a circuit substrate has been placed over the five
crimp posts with individual MLCC chip capacitors.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0119] FIG. 1 illustrates various types of active implantable and external
medical devices 100 that are currently in use. FIG. 1 is a wire formed
diagram of a generic human body showing a number of implanted medical
devices. 100A is a family of external and implantable hearing devices
which can include the group of hearing aids, cochlear implants,
piezoelectric sound bridge transducers and the like. 100B includes an
entire variety of neurostimulators and brain stimulators.
Neurostimulators are used to stimulate the Vagus nerve, for example, to
treat epilepsy, obesity and depression. Brain stimulators are similar to
a pacemaker-like device and include electrodes implanted deep into the
brain for sensing the onset of a seizure and also providing electrical
stimulation to brain tissue to prevent the seizure from actually
happening. The lead wires that come from a deep brain stimulator are
often placed using real time imaging. Most commonly such lead wires are
placed during real time MRI. 100C shows a cardiac pacemaker which is
well-known in the art. 100D includes the family of left ventricular
assist devices (LVAD's), and artificial hearts, including the recently
introduced artificial heart known as the Abiocor. 100E includes an entire
family of drug pumps which can be used for dispensing of insulin,
chemotherapy drugs, pain medications and the like. Insulin pumps are
evolving from passive devices to ones that have sensors and closed loop
systems. That is, real time monitoring of blood sugar levels will occur.
These devices tend to be more sensitive to EMI than passive pumps that
have no sense circuitry or externally implanted lead wires. 100F includes
a variety of external or implantable bone growth stimulators for rapid
healing of fractures. 100G includes urinary incontinence devices. 100H
includes the family of pain relief spinal cord stimulators and
anti-tremor stimulators. 100H also includes an entire family of other
types of neurostimulators used to block pain. 1001 includes a family of
implantable cardioverter defibrillators (ICD) devices and also includes
the family of congestive heart failure devices (CHF). This is also known
in the art as cardio resynchronization therapy devices, otherwise known
as CRT devices. 100J illustrates an externally worn pack. This pack could
be an external insulin pump, an external drug pump, an external
neurostimulator, a Holter monitor with skin electrodes or even a
ventricular assist device power pack. 100K illustrates the insertion of
an external probe or catheter. These probes can be inserted into the
femoral artery, for example, or in any other number of locations in the
human body.

[0120] As used herein, the term "lead" refers to an implantable lead
containing a lead body and one or more internal lead conductors. A "lead
conductor" refers to the conductor that is inside of an implanted lead
body. As used herein, the term "leadwire" refers to wiring that is either
inside of the active implantable medical device (AIMD) housing or inside
of the AIMD header block assembly or both. As used herein, the term
header block is the biocompatible material that attaches between the AIMD
housing and the lead. The term header block connector assembly refers to
the header block including the connector ports for the leads and the
wiring connecting the lead connector ports to the hermetic terminal
subassemblies which allow electrical connections to hermetically pass
inside the device housing. It is also understood by those skilled in the
art that the present invention can be applicable to active implantable
medical devices that do not have a header block or header block connector
assemblies such as pulse generators.

[0121] It is understood that "vias" are defined as holes, apertures,
conduits, or voids created in either insulators or capacitors. A via can
also be filled with a conductive material or bore-coated with a
conductive material such that the inside surface is metalized and
conductively coated. A via in a capacitor will generally be referred to
as a capacitor via. A via in an insulator will generally be referred to
as an insulator via. Accordingly, the terms filled or bore-coated can
also be applied to either capacitor vias or insulator vias.

[0122] FIG. 2 illustrates a prior art cross-section of a different type of
hermetic terminal subassembly substrate. The insulator 120 is a ceramic
substrate formed by roll compaction. After compaction, the leadwire 180
is placed within the insulator via. In this case, the insulator via is
filled with a solid platinum leadwire 180. FIG. 4 is an enlarged view
taken from FIG. 3 showing gaps 182 that are created between the insulator
120 and the leadwire 180. These gaps reduce hermeticity and are very
problematic.

[0123] One is referred to U.S. Pat. Nos. 7,480,988; 7,989,080; and
8,163,397. These three patents share a common priority chain and are
directed to a method and apparatus for providing a hermetic electrical
feedthrough. All three of these patents were assigned to Second Sight
Medical Products, Inc. and will hereinafter be referred to as the "Second
Sight" patents. FIG. 3 of the Second Sight patents is a flow process that
starts with drilling blind holes in a green ceramic sheet. Then lengths
of platinum leadwire 180 are cut and inserted into the sheet holes in
step 39. The ceramic wire assembly is then fired at 1600° C. in
step 44. Second Sight discloses that "during the firing and subsequent
cooling, the ceramic expands shrinking the holes around the wires 38 to
form a compression seal. The shrinkage is believed to occur, at least in
part, as a consequence of polymer binder burnout. The fine aluminum oxide
suspension permits uniform and continuous sealing around the surface of
the wire. Additionally, at the maximum firing temperature, e.g.,
1600° C., the solid platinum wires being squeezed by the ceramic
exhibit sufficient plasticity to enable the platinum to flow and fill any
crevices. This action produces a hermetic metal/ceramic interface."
Further, Second Sight discusses that "After lapping, the feedthrough
assembly comprised of the finished ceramic sheet and feedthrough wires,
is subjected to a hermeticity test, e.g., frequently a helium leak test
as represented by block 56 in FIG. 3." While Second Sight discusses
forming a compression seal and platinum flow to fill any crevices,
creation of mutually conformal interface or tortuous, intimate knitline
between the alumina and the platinum wire is not taught.

[0124] In addition, latent hermetic failures in device feedthrough
terminals have been known to occur due to susceptibility of the glass
phased interface between these mating materials to erosion by body
fluids. This outcome is particularly prevalent for interfaces comprising
silicate glasses that are often a result of the additives to ceramic
slurries forming the tapes and via fill materials that are used to build
multilayer ceramic feedthrough structures. Dissolution of silicate
glasses is composition dependent. In particular, erosion of silicate
glasses in the body typically occurs when the silica content is lower
than about 60%. Silica glasses, as suggested by the name, are based on a
tetrahedral network of atoms comprising silicon and oxygen covalently
bonded to each other. Heat treatment during the assembly process of the
feedthrough structure provides the means by which other elements, such as
alkali and/or alkaline ions, can be introduced into the silica atomic
network. When the glass composition formed at the interface is more than
60% silica, the atomic network within the glass structure typically
becomes resistant to reaction with body fluids due to the dense nature of
the atomic network structure. However, when the glass composition formed
at the interface is less than about 60%, the glass structure is more
susceptible to atomic structural degradation.

[0125] Degradation is generally due to the disruption of the silica atomic
network within the glass structure by other elements, such as alkali
and/or alkaline ions, introduced during binder bake out and sintering.
These other elements are typically introduced into the feedthrough
structure from additives used within the green alumina tape or the via
fill materials, such as the platinum paste, or both. For example, if the
additives in either material make available alkali-metal atoms for
exchange with silicon atoms within the silica atomic network, and if the
result is an interface having a silica weight percent below about 60%,
then rapid ion exchange of the alkali-metal cations with hydrogen ions
from body fluid typically occurs. This results in the formation of
functional hydroxyl, or --OH, groups that are highly reactive in the
body, breaking down and weakening the atomic network structure of the
glass phased interface thus increasing the likelihood of a breach in the
hermeticity of the feedthrough terminal. Hence, hermetic structures
created by mating alumina and platinum are not obvious and any inherency
in the bond developed between these two materials does not necessarily
result in a biocompatible final structure that can sustain hermeticity
over the service life of an AIMD.

[0126] There are a number of patents that disclose hermetic terminals
manufactured by a co-fire process and based on an alumina ceramic with
platinum paste filled vias such as the following: U.S. Pat. No. 5,782,891
to Hassler et al.; U.S. Pat. No. 6,146,743 to Haq et al.; U.S. Pat. No.
6,414,835 to Wolf et al.; U.S. Pat. No. 8,000,804 to Wessendorf et al.;
U.S. Pat. No. 8,043,454 to Jiang et al.; and US Published Applications
2007/0236861 to Burdon et al.; 2007/00609969 to Burdon at al.;
2011/0102967 to Munns et al.; and 2011/0248184 to Shah. None of the prior
art concepts, however, including the prominent concepts noted above,
teaches a structure that has a mutually conformal interface, also called
a tortuous, intimate knitline, that results in sustainable hermeticity
for an AIMD. Further, none of the prior art, including the prominent
concepts noted above, teach a structure, or the manufacture of such a
structure, having residual stress levels such that either matched
hermetic structures or structures that have protectively compressive
stresses from the ceramic part to the filled via at the bonding interface
are created.

[0127] In more detail, U.S. Pat. No. 8,043,454 to Jiang et al. (hereafter
referred to as Jiang) describes a method of making a hermetic via in a
ceramic substrate that is composed of a noble metal powder in a
glass-free paste that contains alumina and a mixture of niobium
pentoxide. The addition of the niobium pentoxide to the pre-sintered
paste prevents shrinkage of the paste during thermal processing and binds
to both the ceramic and the noble metal particulates in the via, thus
maintaining a hermetic seal around the via. Hence, hermeticity in this
case is imparted by niobium pentoxide and not a mutually conformal
interface or tortuous, intimate knitline for a single straight via. Jiang
teaches avoiding CTE mismatches for feedthroughs and compression seals
formed by metal tubing on ceramic insulators, however, Jiang does not
teach structures wherein shrinkage of the ceramic is greater than
shrinkage of the filled via material. Further Jiang does not teach a
terminal or feedthrough having residual stress levels such that matched
hermetic structures or structures that have protectively compressive
stresses from the ceramic part to the filled via material at the bonding
interface are created.

[0128] In more detail, U.S. Pat. No. 6,146,743 to Haq et al. (hereafter
referred to as Haq) teaches hermetically sealed multilayer substrates
with vias. One is directed to Haq FIG. 16 which shows the cross section
of via fill after sintering. Haq discloses that in this structure the
"ceramic powder component also improves the degree of adhesion between
the ceramic forming the substrate itself and external via 66, thereby
ensuring the formation of a hermetic seal in ceramic substrate 50. This
hermetic seal inhibits or prevents internal metallization layers 64 from
becoming oxidized when substrate 50 is air-fired during one method of the
present invention." One is directed to Haq column 21, lines 32-43 where
towards the end of that paragraph it states, "As the unfired green tape
material emerges from the casting tape machine, it is coated with a
castable dielectric composition that upon firing at high temperatures
forms a glass." It is the external via that imparts hermeticity of the
internal vias in this structure, and not a mutually conformal interface
or tortuous, intimate knitline for a single straight via. Regarding
shrinkage, Haq teaches matching shrinkages between ceramic and filled via
material. Haq does not teach a structure wherein shrinkage of the ceramic
is greater than shrinkage of the filled via material. Further Haq does
not teach a terminal or feedthrough having residual stress levels such
that matched hermetic structures or structures that have protectively
compressive stresses from the ceramic part to the filled via material at
the bonding interface are created.

[0129] In more detail, U.S. Pat. No. 8,000,804 to Wessendorf et al.
(hereafter referred to as Wessendorf) illustrates an electrode array for
a neurostimulator. The Wessendorf patent teaches "a plurality of
electrodes arranged in a two-dimensional array and extending through the
ceramic base between the first and second major surfaces; a ceramic lid
having a plurality of electrical connections extending therethrough, with
the ceramic lid being attachable to the ceramic base to form a
hermetically-sealed interior region; and an electronic circuit (e.g. a
demultiplexer circuit) located within the hermetically-sealed interior
region." Hermeticity in this case is imparted by "a two-part ceramic
package which can be hermetically sealed" and not by a mutually conformal
interface or tortuous, intimate knitline for each single straight via.
Wessendorf teaches matching CTEs for ceramic and via fill materials,
however, Wessendorf does not teach structures wherein shrinkage of the
ceramic is greater than shrinkage of the filled via material. Further
Wessendorf does not teach a terminal or feedthrough having residual
stress levels such that matched hermetic structures or structures that
have protectively compressive stresses from the ceramic part to the
filled via material at the bonding interface are created.

[0130] Referring now to U.S. Pat. No. 8,043,454 of Jiang et al., and in
sharp contrast to the present invention, Jiang adds between 1-10 percent
by weight of niobium pentoxide. Another way to look at this is in the
present invention, organic binders and solvents are used as opposed to
inorganic additives. Additives to the platinum via fill 180 such as
disclosed by Haq may result in unfavorable functionality. For example,
the elongate channel-like structures that are actually a result of
additives like ceramic powder can lower electrical conductivity if the
conductivities of these phases are significantly different from the
primary densified material formed. This is discussed in some of the prior
art cited. It is very important for human implant applications that the
resistivity of the filled via holes be as low as possible. The inventors
have found that adding any ceramic powder to the platinum paste
substantially increases the electrical resistivity of the post sintered
via hole. This is a major reason why the inventors have been working over
a number of years to develop a pure platinum sintered via hole. This is
particularly important for AIMDs, such as implantable cardioverter
defibrillators. An implantable cardioverter defibrillator not only senses
electrical activity, but it must be able to deliver a very high voltage
and high current shock in order to defibrillate the patient. This means
that the entire system, including the lead conductors, the hermetic
terminal subassembly via holes, and associated internal circuitry must
have very low resistance and low impedance so that a high current can be
effectively delivered. Furthermore, and as noted above, the creation of a
glassy-phased structure bond (item 184 in FIG. 11A from parent
application Ser. No. 14/182,569) has the potential problem of latent
hermetic leaks when exposed to body fluid. The present invention resolves
this issue.

[0131] In the present invention, a post sintered, essentially high purity
alumina substrate 188 with one or more via holes 186 that pass from an
outside surface of the alumina substrate 188 to an inside surface of the
alumina substrate 188 is provided wherein, the via holes 186 comprise a
non-toxic and biocompatible post sintered, essentially pure platinum
fill. There are several differences between the present invention and the
prior art in addition to those specifically discussed in the brief
overview of specific art cited. In the prior art, typically various
additives are used to modify the alumina ceramic and/or the platinum
paste. In the prior art, at times, it is not even a pure platinum paste
that is used (see Wessendorf column 5, line 29), but rather one
containing other refractory type materials, such as tungsten or the like.
These additives are used to match the CTE during fabrication. In other
words, these prior art systems go to a lot of effort to match the ceramic
and metal parts of the system so that cracking or loss of hermeticity
between the alumina substrate 188 and via 186 does not occur over time.
Additionally, much of the prior art processes lay down a thin layer of
ceramic tape, then use thick-film screen printing or other methods to
deposit circuit traces and filler for the previously fabricated via holes
180. These fillers include tungsten inks and the like. Then, these
individual layers are dried, stacked up and pressed (laminated) into a
bar. There are often registration errors and stair-stepping is visible in
the cross-sections of such vias 180.

[0132] In the present invention, via holes are not formed in individual
tape layers before stack-up. Instead, the alumina ceramic slurry can be
thick-cast into tape and then laid down in layers or it may be injected,
molded, powder pressed or the like to form a single monolithic structure.
In this state, the alumina ceramic is still in the green and very pliable
due to the organic binders and solvents that have been temporarily added
to the system. It is at this point that via holes 186 are drilled
therethrough from the outer surface (body fluid side) to an inner surface
(AIMD electronic side) of the alumina substrate 188. Because the holes
are drilled after formation of the pre-sintered ceramic substrate 188,
there is no requirement for registration with the consequential
"stair-stepping" (due to misregistration) that is visible in cross
sections of some prior art structures, for example those described in the
Second Sight patents.

[0133] After via holes are formed, the pure platinum paste composition is
injected under pressure or via vacuum into the via holes 186. The
pressure or vacuum is carefully controlled in the present invention so
that the platinum paste is driven intimately along the surface of the
inside of the via such that the paste conforms to and creates a mirror
image of the inner surface of the via in the alumina ceramic and, in so
doing, interconnect with the already tortuous members prevalent in
ceramic/particulate formation. A mutually conforming interface 191 is
thereby formed between the platinum fill and the inside diameter of the
via hole in the ceramic. (See FIG. 42) Drilling is a preferred method of
forming the via hole, but these via holes may also be formed by punching,
laser drilling, water cutting or any other equivalent process.

[0134] As used herein, the term "essentially high purity alumina" means
alumina ceramic with the chemical formula Al2O3. "Essentially
pure" means that the post-sintered ceramic is at least 96% alumina. In a
preferred embodiment, the post-sintered ceramic is at least 99% high
purity alumina. Prior to sintering, the alumina may be a paste, a slurry
or green state, and can contain organic solvents and binders. Once these
organic solvents and binders are baked out, the alumina is sintered
becoming essentially high purity alumina. Similarly, prior to sintering,
the platinum paste also contains binders and solvents. The drilled vias
of the ceramic insulator are filled with the platinum paste. It is after
the binders and solvents are baked out at elevated temperature and then
sintered that they are substantially removed and an essentially pure
platinum via hole is created.

[0135] One is referred to FIG. 5 which is a flow chart illustrating the
main steps of the process of the present invention. First, an essentially
high purity alumina substrate is formed. The essentially high purity
alumina can be formed either through injection molding, green machining,
powder pressing 166, by pressing powder into an injection die, or by tape
casting and then stacking and laminating individual layers, under a
pressure ranging from about 1,000 psi to about 5,000 psi at a temperature
ranging from about 60° C. to about 85° C. for about 5
minutes to about 15 minutes into a bar 168. After formation of the bar in
step 168, the via holes are formed preferably by drilling through the
structure, however punching, pressing, laser or waterjet operations may
also be used to form the holes 170. All of the via holes would be filled
in step 172 with an essentially pure platinum paste containing organic
solvents and organic binders. It should be noted that organic solvents
and binders also make up a percentage of the green essentially high
purity alumina substrate. A further clarification is required here. As
used herein, "essentially pure" means essentially pure post-sintering
once the bulk of the binders and solvents have been baked out in step 174
and/or sintered in step 176, both at elevated temperature. Once the
binders and solvents have been driven out of the system and sintering 176
has occurred, the result is a solid monolithic high purity alumina
substrate 188 with one or more pure platinum via holes 186 extending from
an alumina substrate 188 outer surface to an inner surface. The outside
diameter or the perimeter of the alumina substrate can now be prepared
for attaching a ferrule 122. In the present invention, the ferrule 122 is
attached using conventional prior art techniques. That is, the outside
diameter or perimeter of the sintered alumina substrate 188 is metalized
(sputtered). The metallization would typically be in two layers with a
first layer being an adhesion layer 152 and the second layer being a
wetting layer 150. Then the ferrule is attached to these metalized
ceramic layers through a gold brazing process 178 wherein, pure gold is
reflowed such that it wets the titanium ferrule and also wets to the
metalized surfaces that were previously sputtered onto the alumina
ceramic.

[0136] The present invention centers around three enabling areas: (1) via
packing with a high solids loading in the paste, (2) compression by the
ceramic of the metal paste during binder bake out and sintering, and (3)
a controlled cool down rate in combination with interfacial bonding
sufficient to tolerate coefficient of thermal expansion (CTE) mismatch.

[0137] Metal/ceramic compatibility is an important factor in manufacturing
hermetic terminals. The difference in CTEs of the metal and ceramic is
recognized as a major parameter in predicting compatibility. The thermal
expansion of metal is generally considerably greater than those of
ceramics. For example, at a bakeout temperature of 500° C., the
CTE of alumina is 7.8×10-6/K and of platinum is
9.6×10-6/K. Historically, CTE differences within 0.5 to
1.0×10-6/K between the mating metal and ceramic materials are
adequate to sustain hermetic bonding between these materials. However, it
is believed differences beyond these limits provided at the bake out
temperature for the alumina/platinum pair may produce sufficient tensile
stresses at the interface during cool down to cause spontaneous bonding
failure. Hence, given the significant difference in CTEs, even at a
relatively low temperature of 500° C., achieving a hermetic seal
between the platinum metal and alumina ceramic would not be expected if
the difference in CTE between the sintered alumina and the platinum metal
exceeds 0.5 to 1.0×10-6/K. Rather, the present invention
achieves a hermetic feedthrough structure through the controlled
fabrication process parameters of the platinum metal particle solids
loading within the paste, controlled packing of the platinum paste within
the via, and the controlled shrinkage of the alumina substrate and
platinum via paste through a prescribed co-fire heating profile.

[0138] In addition, a highly irregular surface at the material interface
between the alumina substrate and the platinum metal particles within the
via provides a mechanical contribution to adherence and robustness of the
hermetic seal. A surface roughness produced by drill bits, sandblasting,
gritblasting or chemical etching of the metal substrate can increase the
surface area and, in so doing, provide for a stronger mechanical
attachment along the mutually conformal interface. Applying this concept
to the alumina/platinum interface therein provides for another novel
aspect of the present invention. Examples of sandblasting and
gritblasting media include sand, sodium bicarbonate, walnut shells,
alumina particles or other equivalent media.

[0139] In the present invention, to achieve sustainable hermeticity, the
following is required. Because the CTE of platinum is sufficiently higher
than the CTE of alumina, it is not theoretically possible for alumina to
provide compressive forces on a platinum body in a via. Hence, to
overcome the CTE differences between these two materials, the platinum
body in the via must be formed using a paste, a slurry or the like,
having a minimum of 80% solids loading. In one embodiment, the solids
loading of the platinum particles within the paste is 90%. In another
embodiment, the solids loading of the platinum particles within the paste
is 95%. In addition, the via must be packed with the platinum paste to
occupy at least 90% of the available space within each via opening. In an
embodiment, the platinum paste is packed within the via opening to occupy
95% of the space. In another embodiment, the platinum paste is packed to
occupy 99% of the via opening. The shrinkage of the alumina must be no
greater than 20% of that of the platinum fill in the via. In an
embodiment, shrinkage is 14%. In another embodiment, shrinkage is 16%.

[0140] Furthermore, the assembly is exposed to a controlled co-firing
heating profile in ambient air that comprises a binder bakeout portion, a
sintering portion and a cool down portion. A preferred binder bakeout is
at a temperature of between 550° C. to 650° C. A more
preferred binder bakeout is at a temperature of between 500° C. to
600° C. The sintering profile portion is preferably performed at a
temperature ranging from 1,400° C. to 1,900° C. for up to 6
hours. A preferred sintering profile has a temperature between
1,500° C. to 1,800° C. A more preferred sintering
temperature is between 1,600° C. to 1,700° C. The cool down
portion occurs either by turning off the heating chamber and allowing the
chamber to equalize to room temperature or, preferably by setting the
cool down portion at a rate of up to 5° C./min from the hold
temperature cooled down to about 1,000° C. At 1,000° C.,
the chamber is allowed to naturally equalize to room temperature. A more
preferred cool down is at a rate of 1° C./min from the hold
temperature to about 1,000° C. and then allowing the heating
chamber to naturally equalize to room temperature. In so doing, the
desired outcome of achieving a robust hermetic seal is achieved between
the mating materials of the alumina and platinum. It is noted that these
materials have a CTE mismatch beyond the limits heretofor recognized as
adequate for sustained bonding.

[0141] During processing of the platinum fill densities and additionally
during the densification phase, compression is imparted by the alumina
around the platinum within the via due to the shrinkage of the alumina
being greater than that of the platinum. Furthermore, the platinum is
sufficiently malleable at this phase to favorably deform by the
compressive forces being applied by the alumina. The combination of the
platinum solids loading, the platinum packing in the via and the
shrinkage of the alumina being greater than the platinum fill results in
the platinum taking the shape of the mating alumina surface. The amount
of platinum solids loading, its packing percentage within the via and the
malleability of the platinum material all contribute to formation of a
hermetic seal between the platinum and alumina. In addition, the
compressive forces that result from the greater shrinkage of the alumina
substrate than that of the platinum within the via limit expansion of the
platinum and force the platinum to deform such that it forms a hermetic
seal. Thus an interface between the alumina and platinum materials that
conforms to the respective interface surfaces and results in a nearly
exact mirror image of the interfacing surfaces is formed, thereby
creating a hermetic bond therebetween. This mutually conformal interface
is critical, particularly as researchers studying bonding between alumina
and platinum believe that any strength in the bonding between the alumina
and platinum is physical.

[0142] As noted earlier, strong bonding between the alumina and the
platinum is the most important factor in achieving sustainable
hermeticity in feedthrough terminals for AIMDs. The inventors have
learned that the co-fire parameters used to form the hermetic terminals
of the present invention provide unanticipated, but novel benefit of
leveraging the catalytic nature of platinum, that is, platinum's affinity
for certain elements, which enables either direct bonding or formation of
an interfacial layer between the two materials. Analysis of the interface
between the alumina and the platinum of this invention disclosed not only
the creation of an intimate knitline, but, in the case of the interfacial
layer, a hermetic structure that exhibits an amorphous layer at the
knitline comprising the elements platinum, aluminum, carbon and oxygen
that appears to impart resistance to erosion by body fluids. Both these
bonding mechanisms, direct bonding and an amorphous interfacial layer,
offer additional tolerance to the CTE mismatch between these two
materials.

[0143] FIG. 6 now shows a novel wire bond cap 192 has been placed on top
of the via hole 186. In a preferred embodiment, this wire bond cap 192
could be of similar compatible metal, like pure platinum, such that it
could be co-fired, to electrically and mechanically connect to the via
hole fill material 186. This wire bond cap 192 can be placed on the top
side as shown, or the bottom side, not shown, or both sides depending on
the application and how wires would be routed to an implanted lead, an
AIMD connector-header block, or the like. Referring once again to FIG. 6,
the novel cap 192 can be set into a counter-bore hole as shown or it can
be set flush or proud on the top surface of the alumina 188, or any
variation thereof. Referring once again to FIG. 6, an implantable lead
conductor could be connected to a wire bond cap 192 located on the body
fluid side. In general, the implantable lead conductor or header block
leadwire 118 would have a distal electrode in contact with biological
cells.

[0144] It has been demonstrated that in a normal patient environment, a
patient can be exposed to EMI. This EMI can take many forms, such as that
from cellular telephones, airport radars, microwave ovens, and the like.
A new international standard ISO 14117 has evolved, which includes tests
standards to which cardiac pacemakers and implantable defibrillators must
be exposed in order to be qualified by the FDA. There are similar
specifications for cochlear implants and neurostimulators. Accordingly,
it is important to provide EMI filtering at the point of lead conductor
ingress into the interior of the AIMD. It is best to decouple high
frequency interference before it gets inside of the AIMD housing 102.
Once inside an AIMD housing 102 the EMI can undesirably cross-couple or
re-radiate to sensitive circuits where it can disrupt the proper
functioning of the AIMD. In extreme cases, pacemaker inhibition has been
documented which is immediately life-threatening for a pacemaker
dependent patient. Accordingly, there is a need in the present invention,
to provide for EMI filtering at the point of implanted lead ingress into
the implanted medical device housing 102.

[0145] FIG. 7 shows an L-shaped wire bond cap 212. In this case, there is
a hole in the wire bond cap through which a pin 242 is either laser
welded, brazed or the like 238 to the L-shaped wire bond cap 212. This
pin ideally would be of platinum or similar compatible metal. This
assembly is co-fired along with the pure platinum via fill 186 so that a
solid mechanical and electrical connection is made between the pin 240
and the platinum via material 186. There is also a difference in the way
that the interior leadwires 118' are attached to the feedthrough
capacitor 124. This is a special feedthrough capacitor that is
rectangular in shape. The rectangular shape is better understood by
looking at the cross-sectional views shown in FIGS. 8 and 9. FIG. 8 is
taken generally along section 8-8 of FIG. 7. FIG. 9 is generally taken
from section 9-9 of FIG. 7. The view in FIG. 7, therefore, is the end
view of a rectangular structure. The active electrodes 134 are brought
out to the sides of the capacitor, which is better illustrated in FIG. 8.
This allows wire bond pads 246 to be attached to the capacitor.
Attachment is done by thermal-setting conductive adhesives, gold braze,
high temperature sold ers, or the like 248. The capacitor ground plate
set 136 is terminated at its ends. This is important so that the ground
plates 136 do not short to the active electrode plates 134. This makes
subsequent attachment of interior leadwires 118' very easy. Internal
leadwires 118' can be attached to the wire bond pads 246 by thermal sonic
bonding, resistance bonding, resistance welding, soldering,
thermal-setting conductive adhesives, brazes, or the like, 244.

[0146] FIG. 10 illustrates a round quad polar co-fired high purity alumina
(Al2O3) hermetic terminal subassembly with one or more pure
platinum filled vias 186 of the present invention. Shown are novel
L-shaped wire bond pads 250a through 250d, which can be co-fired with the
pure platinum via hole fill 186. Since these wire bond pads 250 are on
the body fluid side, it is important that they be non-toxic and
biocompatible. Ideally, they would be of platinum or similar metal that
was readily co-fired and matched to the CTE of the solid platinum via
fill 186.

[0147] FIGS. 11 through 14 illustrate alternative shapes for the wire bond
pads 250a through 250d previously illustrated in FIG. 10. Each wire bond
pad has one or more respective downwardly extending extrusions 251 in
order to penetrate the via hole platinum paste 186 so that when
co-firing, a solid mechanical and electrical connection is made.

[0148] FIG. 15 shows castellations 254 that have been made (into a square
shape) and the corresponding wire bond pad 252 has also been made square.
This structure would be much more robust during compressing welding
operations during attachment of leadwires 118 where substantial force is
pressed against the wire bond pad. Referring once again to FIG. 15, one
can see that the wire bond pads 252 have a co-machined or co-formed post
256. This post would slip down into the via hole paste 186 and be
co-fired. An ideal material for CTE match would, therefore, be a platinum
post, however, gold, titanium, tantalum, palladium can all be used.

[0149] FIGS. 16 through 23 show alternative embodiments of the header
block connector assemblies such as those previously illustrated. FIGS. 16
and 17 illustrate stampings, which are ideally of platinum or some other
similar biocompatible material. They have a hole 264 for convenient
reception of leadwire 118 which may then be permanently attached by laser
welding.

[0150] FIG. 18 is a sectional view 18-18 taken from FIG. 17 showing the
stamping and cross-section.

[0151] FIG. 19 is a sectional view showing the stamping of FIGS. 16, 17
and 18 co-fired into the novel platinum filled via 186 of the present
invention.

[0152] FIGS. 20 and 21 illustrate another embodiment of stamping 268b now
with fingers 265 that capture the leadwire 118.

[0153] FIG. 22 is an alternative embodiment for the header block connector
assembly 268c, which in this case, has a leadwire 278. The leadwire may
be attached to the bracket 268c by laser welding or the entire assembly
could be co-machined or even formed by metal injection processes. In this
case, the leadwire is a platinum or suitable biocompatible material that
has a CTE that will match that of the platinum filled via 186. In this
case, the leadwire 278 is co-fired with the platinum filled via material
186 to form a solid electrical and mechanical joint.

[0154] FIG. 23 is similar to FIG. 22 except that the header block
connector assembly 268d has a convenient hole 264 for insertion of the
leadwire 118 (not shown) where it can be laser welded.

[0155] FIG. 24 illustrates a co-fired high purity alumina
(Al2O3) hermetic terminal subassembly 189 with one or more pure
platinum filled vias 186 of the present invention, wherein leadwires 118
have been co-fired into the platinum filled vias 186. In other words, the
leadwire 118 is co-fired with the alumina 188 and with the platinum
filled via 186, all in one single operation. Leadwires 118 would be
routed and connected to implantable lead conductors or header block
connector assemblies, as is well known in the prior art. As an
alternative to a platinum leadwire 118, the leadwire 118 may comprise
iridium, rhodium, niobium if a reducing atmosphere is used or palladium
in air if the sintering temperature is low enough.

[0156] FIG. 25 shows that there are staggered vias 186 and 186' that are
filled with pure platinum and connected by a circuit trace 287 between
the stagger. In this case, platinum leadwires 118 have been co-fired into
the upper vias 186'. As previously stated, these leadwires 118 could be
routed to implanted leads, to implanted distal electrodes or header block
connector assemblies of AIMDs. The staggered via is a way of increasing
the reliability and hermeticity of the overall structure.

[0157] FIG. 26 illustrates the co-firing of a novel crimp post 288 into
the platinum filled via 186. Ideally, the crimp post would be of platinum
or similar biocompatible material, which would have a CTE which closely
matches that of platinum. A leadwire 118 (not shown) would be inserted
into the crimp post and then a mechanical crimping tool would be used to
form a mechanical and electrical connection between the walls of the
crimp post and the lead 118. An optional or supplementary laser weld
could also be performed at the point where the leadwire 118 is inserted
into the top of the crimp post 288.

[0158] FIG. 27 is similar to FIG. 26, but illustrates a double crimp post.
On the body fluid side, lead 118 is crimped into the crimp post 290 as
shown. On the device inside, a wire 118' can be inserted and crimped into
the opposite side 291 of the crimp post 290 to make connection to
internal AIMD circuits. As described before, leadwire 118' could be an
inexpensive copper insulated leadwire or, as in this case, a bare
leadwire.

[0159] FIG. 28 illustrates a novel method of header block connector
assembly attachment. The header block connector assembly 104 has been
completely prefabricated in accordance with the present invention and has
leadwires 118 extending down into a novel window 210 of the present
invention. Co-molded or co-formed with the header block connector
assembly 104 is a support structure 302. The header block connector
assembly 104 is shown tilted 90°. There is a co-fired high purity
alumina (Al2O3) hermetic terminal subassembly 189 with one or
more pure platinum filled vias 186 of the present invention with novel
wire bond post 294. These wire bond posts 294 each have a leadwire
protrusion which are inserted into the via holes and are co-fired with
the pure platinum 186. The support structure 302 is designed to slip
between the two rows of bonding posts 294 and provide back support for
them. That is, when one pushes against leadwire 118 very firmly with a
resistance welder, this will prevent a platinum or equivalent post (which
are very ductile) from deforming.

[0160] FIG. 29 illustrates a different type of post 296 which could be
used in FIG. 28. Post 296 has a novel slot 298 which can receive leadwire
118 where a laser weld 300 or the like can be performed. The slot can
also be formed and/or rotated 90 degrees such that it is aligned with the
downward projecting leadwires 118.

[0161] FIG. 30 illustrates a co-fired high purity alumina
(Al2O3) hermetic terminal subassembly 189 with one or more pure
platinum filled vias 186 of the present invention with a novel crimp post
288 similar to that previously illustrated. In this case, the crimp post
288 is designed to receive an external leadwire 118 on the body fluid
side. On the opposite side is the nail head structure 306, which could be
radiused (not shown). In this case, the crimp post assembly 288 is
ideally of platinum or similar material and is co-fired into the platinum
filled via 186 in accordance with the present invention. A feedthrough
capacitor 124 is attached using a solder BGA structure 202. It will be
obvious to those skilled in the art that any of the BGA attachments as
illustrated herein could also be solder dots, solder bumps or dots of
thermal-setting conductive adhesives or epoxies, or the like. In a
preferred embodiment, material 202 could be of thermal-setting conductive
polyimide.

[0162] FIGS. 31 through 35 show alternative embodiments of the crimp posts
288. FIG. 31 illustrates the end view of the nail head 306 as previously
illustrated in FIG. 30. FIGS. 32 through 35 illustrate alternative
embodiments of the nail head structure 288 having respective nail head
ends 306a through 306d.

[0163] FIG. 36 is an perspective view of a hermetic seal sub-assembly 101
shown laser welded 128 into an opening in the housing 102 of an active
implantable medical device, such as a cardiac pacemaker. The ferrule 122
is generally of titanium and in the art, is commonly laser welded 128 as
shown to the device housing 102. There is also a hermetic seal
sub-assembly 187. The hermetic seal sub-assembly 187 is co-fired along
with conductive fill material 186 and a conductive insert 402 into
insulator 188. The conductive insert 402 along with the conductive fill
material 186 is all co-fired along with the formation of the alumina
ceramic insulator 188. In a preferred embodiment, the conductive fill
material 186 would be of substantially pure platinum material and the
conductive insert 402 would be of pure platinum or a platinum alloy. Once
the insulator sub-assembly 187 has been co-fired, its edges can then be
metallized by sputtering 150, 152 such that the entire perimeter
insulator substrate can be gold-brazed 140 into the inside
racetrack-shaped opening of the conductive ferrule 122.

[0164] FIG. 37 shows the device side of the hermetic terminal sub-assembly
shown of FIG. 36. FIG. 37 is very similar to FIG. 36 except that the unit
has been flipped over so one can see the device side on top. Referring
once again to FIG. 37 on the device side, there would be electrical
connections (not shown) to the ends of the conductive insert 402 for
attachment to appropriate location to AIMD electronic circuits. Referring
to FIG. 36, on the body fluid side, there would also be conductive
attachments that would connect between the conductive insert 402 and/or
the conductive fill 186 to various connector locations within an AIMD
header block (not shown). Some AIMDs do not have a header block and
instead have a direct connection from an implanted lead to the hermetic
seal conductor. In this case, an implanted lead (not shown) with five
conductors, would be connected to the five terminal pad locations 402.

[0165] FIG. 38 is taken generally from section 38-38 from FIG. 36 and
shows the hermetic seal sub-assembly 101 in cross-sectional view. In FIG.
38, one can see the sputtered adhesion layer 152 which could consist of
niobium or molybdenum and then followed by sputtering on of a wetting
layer 150 of titanium or the like. Then gold braze material 140 can be
flowed to the titanium ferrule 122 and to the wetting layer 150 thereby
forming a robust, mechanical and hermetically sealed joint. As used
herein, the term hermetic seal means that the hermetic seal sub-assembly,
once it's installed in an AIMD housing, would have a helium leak rate of
no greater than 1×10-7 cubic centimeters per second. Referring
again to FIG. 38, it is a feature of the present invention that the
conductive fill material 186 is conductive from the body fluid side to
the device side. The co-fired conductive insert, which at least partially
fills the conductive via 186 is also conductive. In general, the
conductive paste 186 has a certain resistivity after firing into the
inside of the alumina insulator 188. In the present invention, the
resistance from the body fluid side to the device side can be reduced
significantly by adding a conductive insert 402 at least partially
through the via hole from the device side to the body fluid side. In the
case of FIG. 38, the conductive insert 402 penetrates all the way from
the body fluid side to the device side and therefore would substantially
improve the electrical conductivity between the body fluid side and the
device side. In an embodiment, the resistance from the body fluid side to
the device side would be no more than 2 to 10 milliohms.

[0166] FIG. 39 is taken from sectional view 39-39 from FIG. 36 giving one
another view of the gold braze 140, the wetting layer 150 and the
adhesion layer 152 that are all attached to the perimeter of the
insulator 188.

[0167] Terminals for use in AIMDs comprising a structure co-fired into a
conductive filled via for facilitating a wire attachment require
compliance with the same hermeticity, durability, reliability and
longevity criteria as expected of traditional hermetic terminal options.
Achieving this result, however, offers significant challenge. The
chemical, electrical, mechanical, thermal and manufacturing properties of
the constituents comprising the material system collectively contribute
to a sustainable AIMD terminal hermeticity. Hence, material selection,
terminal design, assembly and co-firing methods are critical. For
example, shrinkage and shrinkage rates may be matched to prevent
development of damaging tensile stresses or selectively different to
create compressive stresses that not only enable sustainable hermeticity
but also support sustainable hermeticity from additional stresses
imparted during wire attachment.

[0168] One embodiment of the present invention is directed to mating bound
particulate conductive particles that are suspended within a mixture of
solvents and binders, i.e., a paste, with a solid conductive structure.
The solid conductive structure may be made from the same material as the
particulate material, of a material with properties similar to the
particulate material, or selectively chosen to be different from the
particulate material to elicit a specific outcome, such as to create a
hermetic compression terminal. The solid conductive structure may be
pretreated to enhance bondability to the paste (e.g., to increase contact
surface area of the solid conductive structure), formability for assembly
(e.g., to reduce stresses imparted by working the material to form the
solid conductive structure), wire attachment and the like.

[0169] Referring once again to FIG. 38, the conductive insert 402 that is
embedded within the conductive filled via must result in an assembly that
results in a conductive solid structure embedded within the conductive
via, such that the packing of the conductive particulate in conjunction
with the conductive solid within it does not alter the loading
requirements to achieve the finished occupied space and resultant
shrinkage for two reasons: achieving and sustaining hermeticity at the
conductive paste/ceramic interface with controlled tensile stress levels
or with ceramic shrinkage to result in a compressive terminal that
sustains hermeticity and supports wire attachment loads.

[0170] FIG. 40 is very similar to FIG. 36 except that in this case, the
conductive inserts 402 can be extended a considerable distance above or
below the entire hermetic seal sub-assembly. For example, conductive
insert 402a is extended into the device side. This could be relatively
short, as shown, or it could be several inches long to make suitable
attachment to circuit attachment points. The same thing is true of the
body fluid side as illustrated in conductive insert 402b, which extends
towards the body fluid side. This could be made long enough to connect
all the way to connector block attachment points (not shown). Insert 402c
illustrates that the conductive insert could extend upwards into the body
fluid side and also downward into the device side achieving both the
aforementioned functions at the same time.

[0171] FIG. 41 is taken generally from sectional view 41-41 from FIG. 40.

[0172] This shows a close-up view of the via filled with the conductive
filled material 186 that is disposed and co-fired within the hermetic
seal insulator 188. The conductive insert 402 is shown. Referring once
again to FIG. 41, one can see that the surface of the conductive insert
402 has been roughened. For example, the solid conductive structure may
be annealed, outgassed, plated, plasma etched, chemically etched,
abraided, micro bead blasted, grit blasted, solvent cleaned, anodized,
and the like prior to assembling and co-firing. The mating materials may
be co-fired utilizing Low Temperature Co-Fired Ceramic (LTCC) or High
Temperature Co-Fired Ceramic (HTCC) methodology, or some combination of
both. Co-firing may also comprise additional steps, for example but not
limited to, brazing, soldering or use of sacrificial volume materials.

[0173] FIG. 42 is taken generally from partial section 42-42 from FIG. 41
and shows the mutually conforming interface between the conductive fill
material 186 and the inside surface of the co-fired alumina ceramic
insulator 188. As previously described in U.S. Pat. No. 8,653,384, the
entire contents of which are incorporated herein by reference, one will
see that this surface, as shown in FIG. 42, is torturous and mutually
conforming, meaning that the peaks and valleys of this surface 191 are
completely filled in by the closely co-bonded and fired conductive fill
186. This is very important to form both a physically strong and highly
hermetic seal joint.

[0174] FIG. 43 is taken generally from partial section 43-43 from FIG. 41
and illustrates the highly desirable roughened surface 191' of the
conductive insert 402. This roughened surface acts very similar to that
previously described in FIG. 42 in that, this gives a place for the
conductive fill material 186 to lock in and form a very mechanically
strong and hermetic bond.

[0175] Referring once again to FIG. 42, one can see the interfacial knit
line 191 that is formed between the co-fired alumina 188 and the
conductive fill 186. In FIG. 42, one will notice that it is perfectly
acceptable for the conductive fill to have some closed porosity holes 190
as shown. These can vary in size, as shown in 190' and 190''. It is very
important in the present invention and is previously described in U.S.
Pat. No. 8,653,384 that these not be open cells such that a continuous
hermetic leak path could be formed.

[0176] FIG. 43 shows a close-up of the knit line 191' that is formed
between the conductive fill material 186 and the solid metal of
conductive insert material 402. One can see that it is highly desirable
that the surface 191' be rough and that the conductive fill material,
upon co-firing, forms a tight bond thereby filling in all the peaks and
valleys along that roughened surface.

[0177] FIG. 44 is very similar to FIG. 41 except that the conductive
insert 402 is surrounded by a plating, a coating or a cladding material
410. This type of structure is also known as drawn filled tubing. For
example, the core or the inside of the conductive insert 402 could be of
pure silver and the cladding 410 could be MP35N. The advantage of the
silver would be extremely high conductivity and the advantage of the
cladding would be to completely coat the silver, including particularly
the body fluid side, such that the conductive insert was not only
conductive, but also completely non-toxic and biocompatible. In one
embodiment, it would only be necessary to have the biocompatible coating
410 on the body fluid side. Since body fluids cannot enter the
hermetically sealed housing of the AIMD, it is not important for the
device side to have a coating 410. In fact, it could be an advantage to
enhance solderability or wire bond attachment to not have the cladding
410 on the device side as shown.

[0178] FIG. 45 is taken from section 45-45 of FIG. 36 and is very similar
to FIG. 38 except that the conductive inserts 402' have a nail head
feature 403. This provides a large surface area for which to attach a
conductor, such as a lead conductor or a header block conductor by a
laser weld or the like. Referring once again to FIG. 45, this nail head
feature could be inverted and directed toward the device side. In this
case, this would facilitate wire bonding, soldering or making connection
to circuit boards on the inside of the device (not shown).

[0179] FIG. 46 is taken from section 46-46 of FIG. 36 and very similar to
FIG. 45 which shows a nail head feature 403 on each of the inserts 402''
and 402'''. Since the diameter of the via with the conductive fill 186 is
smaller than the nail head, a two part construction is utilized. It is
not necessary that a metallurgical bond be formed between the top 402''
and the bottom 402''' of the conductive pads and conductive insert. The
formula for resistivity is R=pl/a wherein, p is the resistivity, l is the
length of the conductor and a is the cross-sectional area. So as long as
the gap between the top conductive insert 402'' and the bottom of the
second conductive insert 402''' is not very great, then the resistivity
from top to bottom will be desirably very low.

[0180] In the present invention, it is very important that the via
consisting of fill material 186 and a solid insert 402 be of extremely
low resistivity as measured from top to bottom. That is, from the body
fluid side to the device side. There are a number of reasons for this. In
a therapeutic pacing application, such as a cardiac pacemaker or a
neurostimulator, pacing pulses pass from the device electronics through
this filled via 186, 402 to an implanted lead and one or more of its
associated electrodes. A voltage drop caused by excessive resistance in
the via could not only degrade pacing pulses but it would also be
wasteful of precious battery energy. Low resistivity is even more
critical in high voltage pulse applications, such as for implantable
cardioverter defibrillators. An ICD must deliver a very fast rise-time
high voltage shock (above 700 volts) to properly cardiovert a
fibrillating heart. If the rise-time of the magnitude of the pulse is
degraded, it will not be nearly as effective. In summary, it is a primary
feature of the present invention that a co-fired filled via hole be
achieved, which is extremely low in resistance from the device side to
the body fluid side. In an embodiment, this resistance would be less than
10 milliohms. In another embodiment, this resistance would be less than 2
milliohms.

[0181] FIG. 47 is similar to FIG. 38 except that the conductive inserts
404 are in the form of hollow tubelets. Again, like all of the conductive
inserts of the present invention, these are co-fired with the conductive
paste 186 and the alumina insulator 188. The crimp posts 404 extend to
the body fluid side to receive wires coming from an AIMD header block or
from an AIMD implanted lead 412. As shown, the lead conductor 412 is
inserted inside the crimp post opening 406 and then a crimp 414 is formed
as shown, which makes a solid electrical and mechanical connection. This
also can be backed up with a laser weld (not shown) to effect a
metallurgical connection as well.

[0182] FIG. 48 shows the hermetic terminal assembly with a crimp post 404
inverted so one can see the device side. In this case, the crimp post
only partially fills the via hole with the conductive fill. In other
words, it does not go all the way through from the device side to the
body fluid side. This feature is best shown in FIGS. 49 and 50, which is
taken from section 49-49 and 50-50 from FIG. 47. In this case, one can
see that the top and bottom of the conductive fill via 186 has been
enlarged with a counterbore to increase the contact surface area and also
to provide an area for co-firing of the crimp post 404 which has a hollow
center 406. It is desirable that the conductive fill is shown
mechanically and electrically attached to both the outside diameter 404
and the inside diameter 404 of the tube, such that suitable pull strength
is achieved.

[0183] FIG. 50 is generally taken from section 50-50 from FIG. 47 and
shows a cross-section right through the center line of the hermetic seal
assembly. One can see the cross-section of the crimp tube 406 solidly
embedded in the conductive fill material 186 as shown.

[0184] FIG. 51 is very similar to FIG. 49 except in this case, there are
crimp posts 404 and 404' positioned on both the body fluid side and the
device side. In this way, body fluid side attachments could be made to
leadwires or lead conductors and electrical circuit connections can be
made to electronic circuits (not shown) inside of the AIMD housing.
Referring once again to FIG. 51, one can see that on the body fluid side
that the crimp post 404 would have to be of non-toxic and biocompatible
materials, such as platinum and the like. However, on the device side,
for example, where crimp post 404' is shown, these could be inexpensive
and non-biocompatible materials, such as copper since they are not
exposed to body fluids. Referring once again to FIG. 51, the conductive
fill material 186 has a lower conductivity in comparison to the solid
metal crimp post material 406. The long and relatively narrow section of
the conductive fill via that's between the top and bottom counterbores
therefore, is relatively undesirable since it will create resistance
through the via from the body fluid side to the device side.

[0185] Another embodiment is shown in FIG. 52, wherein one can see that
the crimp post 404 passes through a larger diameter conductive fill via
186. In addition, the top crimp post 404 comes very close to touching the
bottom crimp post 404'. In this case, the electrical conductivity from
the body fluid side to the device side is greatly reduced. An optional
configuration is shown in FIG. 27 wherein, the crimp post or tube is
continuous from top to bottom thereby affecting the lowest resistivity
possible.

[0186] FIG. 53 is very similar to FIG. 52 except in this case, there is a
slit/slot 408 along the edge of the crimp post 404 which allows it to be
easily crushed down onto a leadwire (not shown).

[0188] FIG. 55 is taken from section 55-55 from FIG. 53 showing the
slotted crimp post in side view.

[0189] FIG. 56 is taken from section 56-56 from FIG. 53 again showing the
slotted 408 crimp post 404.

[0190] FIG. 57 is very similar to FIG. 53 except that the crimp post 404
has double slots 408 as shown. Again, this would be to facilitate
crimping or crushing down the tube of a smaller diameter lead conductor
(not shown) that would be inserted into the inner diameter 406.

[0193] FIG. 60 is taken from section 60-60 from FIG. 57 right through the
center of the device, this time going through the center of both slots
408.

[0194] FIGS. 61 and 61A through 65 and 65A show alternative configurations
for either partial or fully through crimp posts.

[0195] FIG. 66 has a single slot 408 in the crimp post 404. This is very
similar to FIG. 47 except that the crimp post 404 is continuous all the
way through the via from the body fluid side to the device side.

[0196] FIG. 67 shows the perspective view of FIG. 66 inverted so one can
see the device side. In this case, there is a single slot 408 shown. It
will be understood by those skilled in the art that this could be a
double slot or even multiple slots to achieve optimal crimping.

[0197] FIG. 68 is taken from section 68-68 from FIG. 66 illustrating that
the slotted crimp post 404 extends all the way through the conductive
filled via from the body fluid side to the device side. An advantage to
this type of arrangement is that very inexpensive wires can then be used
on the device side. For example, commercially available insulated 415
copper wires 413 can be crimped 412 on the device side and routed to
convenient circuit board locations. This is far less expensive than
running, for example, platinum wiring inside of a device. Again, inside
of a device, noble materials and biocompatibility are not required since
there is no exposure to body fluid or tissues.

[0198] FIG. 69 is taken from section 69-69 from FIG. 67, again
illustrating how the conductive fill 186 penetrates both the outside and
the inside diameter of the crimp post 404. This gives the crimp post 404
a great deal of mechanical strength particularly in pull or sheer test.

[0199] FIGS. 70A through 70F illustrate different top views for the crimp
post arrangements previously described. FIG. 70A is a top view of a
single slotted 408 crimp post 404. FIG. 70B is a top view of a double
slotted 404 crimp post. FIG. 70B could also be formed from two completely
separate semi-circular pieces of solid metal which are then co-fired into
the conductive fill to form the crimp post structure. FIG. 70C
illustrates that three separate pieces could be used resulting in three
slots 408. FIG. 70D is very similar to FIG. 70C except that in this case,
there are four pieces. FIG. 70E illustrates a single slot oval shaped
through crimp post whereas, FIG. 70F illustrates that it could take on
any other shape, such as square, rectangular or the like.

[0200] FIG. 71 illustrates that any of the novel hermetic seals of the
present invention can have a mounted feedthrough capacitor 124. In this
case, an electrical connection 416 is made from each of the feedthrough
capacitor center holes to each individual crimp post 404, which could be
a solder, thermal-setting conductive adhesive or the like. There is also
a suitable electrical connection made from the capacitor outside
perimeter metallization 419 to the ferrule 122. The electrical connection
material 420 could be continuous or discontinuous as shown. In a
preferred embodiment, the electrical connection 420 would be between the
capacitor outside perimeter ground metallization 419 into gold brazed
areas on the hermetic seal ferrule 122, such that no oxides of titanium
could build up in the electrical connection which could preclude proper
high frequency attenuation of the filter.

[0201] FIG. 72 illustrates an alternative filter embodiment wherein, a
circuit substrate 422 has been placed over the five crimp posts 404.
There are five individual MLCC chip capacitors 194, which are mounted to
circuit traces that are already pre-printed on the circuit board 422.
Again, an electrical connection would be made from the circuit board via
hole end to each of the crimp posts 404. In addition, the capacitors
would all be connected to a ground circuit trace 418 or individually
grounded to a gold braze area as shown.

[0202] Although several embodiments have been described in detail for
purposes of illustration, various modifications may be made to each
without departing from the scope and spirit of the invention.
Accordingly, the invention is not to be limited, except as by the
appended claims.